AccessGUDID - DEVICE: Bite Blocks (00190746074288)

GUDID

Device Identifier (DI) Information

Brand Name: Bite Blocks
Version or Model: 855-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 855-200
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746074288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: DB LINGUAL BITE BLOCK SHORT 10/PKG

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62683	Tongue-training dental orthosis	A non-sterile intraoral device intended to be fixed/cemented to the teeth long-term (> 30 days) to stimulate the tongue to reposition itself during swallowing, speech, and resting posture to retrain the tongue such as to reduce the pressure on the teeth. Often referred to as a lingual spur it includes a sharp/pointed stem(s) intended to discourage undesirable tongue positioning, and is often used in conjunction with preventing/reducing overbite. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYT	MAINTAINER, SPACE PREFORMED, ORTHODONTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: afb9585f-d7ce-4b9f-946c-445fcedea641
Public Version Date: December 31, 2024
Public Version Number: 4
DI Record Publish Date: June 24, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)558-7687
Email: info@americanortho.com

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